20 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
FDA 510(k)
FDA Class 1
·Dental
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776204785·Formed Cystotome m m Tip g
POINT 4 FLOWABLE 2
FDA 510(k)
FDA Class 2
·Dental
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
audifon
FDA UDI
audifon GmbH & Co. KG·EADF023171904332517201·RITE-TRT
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2025
CP840442 DE LEIPZIG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·May 12, 2010
CP025369 DE LEIPZIG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·August 3, 2011
CP85315 IT MODENA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·January 14, 2013
CP84050 FR LA REUNION
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·May 17, 2012
CP84042 DE LEIPZIG %
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·April 20, 2011
D905 DIDECO EOS SINGLE HVR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·September 25, 2013
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 9, 2013
AFFINITY 3
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·March 15, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·October 20, 2025
D905 EOS OXYGENATOR (PHISIO TREATED)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·July 13, 2018
D905 EOS PHISIO OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·August 8, 2017
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024